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NEWS LETTER 2019.(VOL.45)

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[Newsletter No.45] Understanding amended Korea REACH through comparison with EU-REACH

< D-90 until Pre-regsitration>

Understanding amended Korea REACH through comparison with EU-REACH

According to amended K-REACH implemented as of January 1stst, 2019, existing chemical imported or manufactured 1 ton or more per year needs to be pre-registered by June 30th of 2019 and jointly registered gradually depending on its tonnage band.

Following table summarizes obligations of amended K-REACH and compares corresponding items under EU-REACH.

ISSUE & FOCUS

< Comparison points for Korea REACH and EU REACH >

< Comparison points for Korea REACH and EU REACH >

	Korea REACH (revised version)	EU REACH
Pre-registration	⃝ (Tonnage band, C&L and use) → Should update for change	⃝ (Tonnage band) → One time
Registration	New chemicals ≥100kg/year → Notification for <100kg/year of new chemicals	New & existing chemicals ≥ 1 ton/year
Registration	All existing chemical ≥1 ton/year	New & existing chemicals ≥ 1 ton/year
Polymer	Not exempt from registration → Polymer registration or exemption of registration for LCP	Exempt from registration, but its monomer needs to be registered
Data requirements	Higher volume, more data 0.1-1 (only for new chemical from 2020), 1-10, 10-100, 100-1000, and ≥1,000 ton CSR required for ≥ 10 ton/year → Simplified data allowed depending on GHS classification of existing chemical	Higher volume, more data 1-10, 10-100, 100-1000, and ≥1,000 ton CSR required for ≥ 10 ton/year
Duplicating animal testing	Possible for specific condition	Not allowed
Joint submission	⃝ (Mandatory, but opt-out possible)	⃝ (Mandatory, but opt-out possible)
Late pre-registration	⃝ (Before manufacture or import)	⃝ (12 months prior to registration grace period)
Only Representative*	⃝	⃝

* OR conditions: A native person having Korean citizenship or a business unit having an address in Korea under K-REACH.

1. Pre-registration

K-REACH: Information submitted for pre-registration such as tonnage band, classification & labelling and use should be updated if any changes occur.

Change notification should be made

Within 1 month from the date when change occurs, if :

● Notified range of annual manufacture or import quantity has changed
● Contact number, address or company name of the applicant has changed
● (If you are an OR), there is a change in list of substance importers
● (If you are a consignor of chemical notified), there is a change in list of manufacturer of chemicals consigned

Within 1 month from the date when change is known, if :

● Labelling and classification of chemical substance has been changed.
● New consumer use is identified or any use information under 55 use classification has been changed.

EU-REACH: Tonnage band is required for information submitted for pre-registration. Once-off task.

2. Registration

K-REACH: Registration of new chemical is also required for 100 kg and above per year. Notification is required for new chemical which is manufactured or imported less than 100 kg per year. Likewise, any existing chemical with manufactured or imported volume of 1 ton and above per year is required to register.

EU-REACH: Registration is required for any existing or new chemicals manufactured or imported volume of 1 ton and above per year.

3. Polymer

K-REACH: Any polymer is required to be registered. However, polymers meeting corresponding exemption criteria may apply for an exemption as low concern polymer (LCP).

EU-REACH: Registration of polymer is not necessary, but its monomer is required to be registered.

4. Data requirements

K-REACH: Generally, more data is required for higher tonnage band. However, for existing chemical which is not classified according to GHS classification, the required data can be less. CSR is required for the registering tonnage band 10 tons and above. Registration of new chemical in volume band of 0.1 to 1 ton will also require some data and this requirement commences from 2020.

EU-REACH: Required data increases for higher tonnage band. CSR is required for the registering tonnage band above 10 tons.

5. Duplicating animal testing

K-REACH: It is possible if there is a credible reason for duplicating animal testing. For example, in consideration of purchasing cost of existing vertebrate animal data, it may be allowed to generate a new vertebrate animal testing.

EU-REACH: Duplication of animal testing is prohibited.

6. Late pre-registration

K-REACH: It can be carried out before the manufacture or import in case the tonnage exceeds one tonne per year.

EU-REACH: Late pre-registrations have to be submitted.
● within six months after exceeding the one tonne per year threshold; and
● no later than 12 months before the relevant registration deadline.

7. Only Representative (OR)

K-REACH & EU-REACH: A foreign company may appoint local legal entity as OR to comply with each law.

Chemtopia Co., Ltd. provides corresponding services to comply with amended and legislated regulations :

· Chemical registration service including Pre-registration, OR service, Read-across or QSAR approach, CSR preparation, Data sharing and negotiation
· Chemical inventory for regulatory tracking
· Support of regulatory monitoring and volume tracking with chemical management system
· Provision of domestic and foreign chemical regulatory database
· MSDS and label authoring system
· Test arranging & its monitoring with domestic and foreign test institutes

This newsletter is available in Korean, English, and Japanese

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